What is VELSIPITY?

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VELSIPITY is a prescription medicine used to treat adults with moderately to severely active ulcerative colitis.

It is not known if VELSIPITY is safe and effective in children.

Do not take VELSIPITY if you:

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have had a heart attack, chest pain (unstable angina), stroke or mini stroke (transient ischemic attack or TIA), and certain types of heart failure requiring hospitalization in the last 6 months.

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have or have had a history of unusual heartbeats (arrhythmia) that is not corrected by a pacemaker.

Talk to your healthcare provider before taking VELSIPITY if you have any of these conditions or do not know if you have any of these conditions.

Before taking VELSIPITY, tell your healthcare provider about all of your medical conditions, including if you:

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have a serious infection or an infection that does not go away or that keeps coming back (chronic).

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are unable to fight infections due to a disease.

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have received a vaccine in the past 4 weeks or are scheduled to receive a vaccine. You should be brought up to date with all age required vaccines before starting treatment with VELSIPITY. VELSIPITY may affect how well a vaccine works. Tell your healthcare provider that you are receiving treatment with VELSIPITY before receiving a vaccine.

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have chickenpox or received the vaccine for chickenpox. Your healthcare provider may do a blood test for the chickenpox virus. You may need to get the full course of the chickenpox vaccine and then wait 4 weeks before you start taking VELSIPITY.

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have a slow heart rate.

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have an irregular or abnormal heartbeat (arrhythmia).

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have heart disease, Class I or II heart failure, history of a heart attack, high blood pressure or uncontrolled high blood pressure.

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have cerebrovascular disease or history of a stroke or ministroke.

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history of repeated fainting.

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have or have had liver problems.

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have or have had skin cancer.

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have breathing problems, including untreated sleep apnea.

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are pregnant or plan to become pregnant. VELSIPITY may harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant. If you are a female who can become pregnant, you should use effective birth control during your treatment with VELSIPITY and for 7 days after you stop taking VELSIPITY. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant while taking VELSIPITY or within 7 days after you stop taking VELSIPITY.

Pregnancy Registry: There is a registry for women who become pregnant during treatment with VELSIPITY. If you become pregnant while taking VELSIPITY, talk to your healthcare provider about registering with the VELSIPITY Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Either you or your healthcare provider can contact this registry by calling 1-800-616-3791.

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are breastfeeding or plan to breastfeed. It is not known if VELSIPITY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take VELSIPITY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using VELSIPITY with other medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken:

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medicines to control your heart rhythm (antiarrhythmics), heartbeat, or blood pressure. These may be called beta blockers or calcium channel blockers.

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medicines that affect your immune system.

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certain medicines known as moderate to strong inhibitors of both CYP2C9 and CYP3A4, medicines such as fluconazole. If you are taking fluconazole, you should not take VELSIPITY.

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Rifampin. If you are taking rifampin, you should not take VELSIPITY.

You should not receive live vaccines at least 4 weeks before starting VELSIPITY, during treatment with VELSIPITY and for 5 weeks after you stop taking VELSIPITY. Talk to your healthcare provider before you receive a vaccine during treatment and for 5 weeks after treatment with VELSIPITY. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with VELSIPITY.

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of your medicines to show the list to your healthcare provider and pharmacist when you get a new medicine.